MPA RSS news -This is an RSS file. You can use it to subscribe to this data in your favourite RSS reader, such as GoogleReader, or to display this data on your own website or blog. Subscribe to this data using MyMedWorm.Subscribe to this data using GoogleReader.Subscribe to this data using Bloglines.Subscribe to this data using MyYahoo.

This page shows you the latest items in this publication.

Pages: 1 2

59 records returned

EU-Presidency Conference on Sustainable Development and PharmaceuticalEmail this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
On 10-11 November the Medical Products Agency hosted a European Conference on “Sustainable Development and Pharmaceuticals”. EU environmental and health authorities, the Commission, Parliament, the European Medicines Agency EMEA, industry and academia attended the meeting which took place in Uppsala. (Source: MPA RSS news -)
Source: MPA RSS news - - November 16, 2009 Category: Medical Equipment Authors: Medical Products Agency, Sweden Source Type: organizations

Summary of ADR reports in Sweden with Pandemrix (received up to November 10)Email this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
As of today, about 2.1 million doses of Pandemrix have been distributed in Sweden. In total, almost six hundred adverse drug reaction (ADR) reports have been received by the MPA from Health Care Professionals and close to 900 reports from Consumers. The ADR reporting pattern is generally consistent with the expected pattern seen previously in the clinical trials. In this compilation of ADRs reported in Sweden with Pandemrix, allergic reactions, neurological reactions and reactions in children are specifically addressed. (Source: MPA RSS news -)
Source: MPA RSS news - - November 12, 2009 Category: Medical Equipment Authors: Medical Products Agency, Sweden Source Type: organizations

Summary of adverse drug reaction reports in Sweden with PandemrixEmail this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
As of today, about 1.4 million doses of Pandemrix have been distributed in Sweden. In total, about two hundred adverse drug reaction (ADR) reports have been received by the MPA from Health Care Professionals and between 400-500 reports from consumers. The ADR reporting pattern does not deviate from what has been seen in the clinical trials. However, there is particular reason to follow reports of allergic reactions. (Source: MPA RSS news -)
Source: MPA RSS news - - October 29, 2009 Category: Medical Equipment Authors: Medical Products Agency, Sweden Source Type: organizations

24th Meeting of Competent AuthoritiesEmail this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
Early in the Swedish presidency of the EU, the 24th meeting of Competent Authorities for Medical Devices took place in Uppsala on 2-3 July 2009. Participants from EU member states and European Commission representatives discussed a number of important issues on the future of regulating medical devices. (Source: MPA RSS news -)
Source: MPA RSS news - - July 6, 2009 Category: Medical Equipment Authors: Medical Products Agency, Sweden Source Type: organizations

Updated list with active substances participating in PSUR WorksharingEmail this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
The list at Heads of Medicines Agencies is now updated with the latest information and additional specification. (Source: MPA RSS news -)
Source: MPA RSS news - - July 2, 2009 Category: Medical Equipment Authors: Medical Products Agency, Sweden Source Type: organizations

Improving patient safety in the EU: Many Medical Information Systems should be classified as Medical DevicesEmail this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
Correctly functioning Information Technology (IT) systems for health care is a prerequisite for ensuring patient safety. However, applicable regulation is rarely applied, mainly due to the lack of useful guidelines on how to classify the IT-systems. A national working group in Sweden has prepared a guidance report that will help increase compliance with the Medical Device regulation in the EU, thus improving patient safety. (Source: MPA RSS news -)
Source: MPA RSS news - - June 17, 2009 Category: Medical Equipment Authors: Medical Products Agency, Sweden Source Type: organizations

Joint scientific advice meetings with the TLV and the MPAEmail this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
Collaboration between the Dental and Pharmaceutical Benefits Agency (TLV) and the Medical Products Agency (MPA) offers new opportunity for joint scientific advice meetings. (Source: MPA RSS news -)
Source: MPA RSS news - - June 4, 2009 Category: Medical Equipment Authors: Medical Products Agency, Sweden Source Type: organizations

The Medical Products Agency accepts electronic-only submissions for human medicinal products within all proceduresEmail this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
From 1 April 2009, the MPA accepts electronic-only for submissions for human medicinal products within the National Procedure, the Mutual Recognition Procedure and the Decentralised Procedure. The MPA already accepts electronic-only submissions within the Centralised Procedure. (Source: MPA RSS news -)
Source: MPA RSS news - - April 1, 2009 Category: Medical Equipment Authors: Medical Products Agency, Sweden Source Type: organizations

Serious hepatic reactions associated with the dietary supplement FortodolEmail this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
Herb-based dietary supplement contained active drug substance. (Source: MPA RSS news -)
Source: MPA RSS news - - February 25, 2009 Category: Medical Equipment Authors: Medical Products Agency, Sweden Source Type: organizations

Singapore and Sweden sign memorandumEmail this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
Singapore’s Health Sciences Authority (HSA) and its Swedish regulatory counterpart, the Medical Products Agency (MPA) have signed a Memorandum of Understanding (MOU) in the regulation of health products. (Source: MPA RSS news -)
Source: MPA RSS news - - November 28, 2008 Category: Medical Equipment Authors: Medical Products Agency, Sweden Source Type: organizations

Batches of Klexane in quarantineEmail this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
Some batches of Klexane are placed into quarantine. This is a precautionary measure while the MPA awaits the result of an audit of the full supply-chain in China. (Source: MPA RSS news -)
Source: MPA RSS news - - September 29, 2008 Category: Medical Equipment Authors: Medical Products Agency, Sweden Source Type: organizations

Recall of contaminated KlexaneEmail this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
On 23 April 2008, the Medical Products Agency decided to recall the contaminated batches of Klexane found on the Swedish market. The level of contamination is low and the recall was made as a precautionary measure. (Source: MPA RSS news -)
Source: MPA RSS news - - April 29, 2008 Category: Medical Equipment Authors: Medical Products Agency, Sweden Source Type: organizations

MPA fully booked for Decentralised Procedures until mid 2009Email this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
The Medical Products Agency (MPA) has received a high number of requests to act as Reference Member State for the Decentralised Procedure over the last years. As a result of this the MPA is fully booked for 2008 and the first 6 months of 2009. Read more about what you should do as an applicant. (Source: MPA RSS news -)
Source: MPA RSS news - - February 28, 2008 Category: Medical Equipment Authors: Medical Products Agency, Sweden Source Type: organizations

Dental implants NobelDirect and NobelPerfect: restraints rescinded and review concludedEmail this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
The Medical Products Agency has now concluded its review of the dental implants NobelDirect and NobelPerfect. The company, Nobel Biocare has improved the instructions for use for the implants and therefore these can be sold again without restraints. (Source: MPA RSS news -)
Source: MPA RSS news - - February 26, 2008 Category: Medical Equipment Authors: Medical Products Agency, Sweden Source Type: organizations

EU Paediatric Regulation - new demands on market authorisation holdersEmail this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
The main object of the new EU paediatric regulation starting 26th of January 2007 is to improve the health of children by better regulation of medicines used for children. All available results of paediatric studies and trials should be submitted by marketing authorisation holders to the national competent authorities or to the EMEA before 26 January 2008. Further paediatric studies should be submitted on an ongoing basis within six months of their completion. (Source: MPA RSS news -)
Source: MPA RSS news - - November 9, 2007 Category: Medical Equipment Authors: Medical Products Agency, Sweden Source Type: organizations

Notification to all Relevant Marketing Authorisation Holders - Backlog Reporting to the EudraVigilance DatabaseEmail this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
All spontaneous reports and reports from non-interventional studies with events that occurred in Sweden should be reported directly to the EMEA (EudraVigilance database) before January 1st, 2008, if not previously reported electronically to the MPA. (Source: MPA RSS news -)
Source: MPA RSS news - - November 8, 2007 Category: Medical Equipment Authors: Medical Products Agency, Sweden Source Type: organizations

Notification to all Relevant Marketing Authorisation Holders - Backlog Reporting to the EudraVigilance DatabaseEmail this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
All spontaneous reports and reports from non-interventional studies with events that occurred in Sweden should be reported directly to the EMEA (EudraVigilance database) before February 1st, 2008, if not previously reported electronically to the MPA. (Source: MPA RSS news -)
Source: MPA RSS news - - November 8, 2007 Category: Medical Equipment Authors: Medical Products Agency, Sweden Source Type: organizations

Contents of slimming preparations and similar products called into questionEmail this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
The Medical Products Agency (MPA) and the National Food Administration (NFA) have jointly carried out a study concerning the contents of a number of slimming preparations and similar products, purchased at the Internet with the principal aim to control the contents of substances with well known safety problems. The analyses were carried out at the MPA’s laboratory. The selection of products included in this study does not claim to be complete. (Source: MPA RSS news -)
Source: MPA RSS news - - October 26, 2007 Category: Medical Equipment Authors: Medical Products Agency, Sweden Source Type: organizations

From paper to electrons - Swedish Medical Products Agency automates case managementEmail this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
By 2010 the Swedish Medical Products Agency will have introduced a new working method, using automated case management and information management in electronic form instead of the current paper-based system. “The new working method gives the agency the opportunity to concentrate more on its core activity,” says Director-General Gunnar Alvan. (Source: MPA RSS news -)
Source: MPA RSS news - - October 23, 2007 Category: Medical Equipment Authors: Medical Products Agency, Sweden Source Type: organizations

Dr. Tomas Salmonson appointed to represent Europe at the ICH Steering CommitteeEmail this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
On Friday October 5th, Dr. Tomas Salmonson from the Swedish Medical Products Agency was appointed by the European Commission to represent the EU at the ICH Steering Committee. (Source: MPA RSS news -)
Source: MPA RSS news - - October 8, 2007 Category: Medical Equipment Authors: Medical Products Agency, Sweden Source Type: organizations

New Director at the Medical Products AgencyEmail this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
Lena Björk, has been appointed new director at the Medical Products Agency, with responsibility for assessment and regulatory units. (Source: MPA RSS news -)
Source: MPA RSS news - - September 6, 2007 Category: Medical Equipment Authors: Medical Products Agency, Sweden Source Type: organizations

Nobel Biocare improves information on dental implantsEmail this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
Nobel Biocare has completed the plan for improving the information about the dental implants NobelDirect and NobelPerfect. The company has complied with the main points required by the Medical Products Agency. (Source: MPA RSS news -)
Source: MPA RSS news - - September 3, 2007 Category: Medical Equipment Authors: Medical Products Agency, Sweden Source Type: organizations

Inform about marketing of medicinal products – Sunset clauseEmail this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
Marketing authorisation holders (MAH) are required to inform the Medical Products Agency if their approved medicinal products are available on the Swedish market or not. (Source: MPA RSS news -)
Source: MPA RSS news - - July 12, 2007 Category: Medical Equipment Authors: Medical Products Agency, Sweden Source Type: organizations

Evaluation of the Medical Products Agency’s Scientific AdviceEmail this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
Starting August 1st, the Medical Products Agency will begin to evaluate its routine for Scientific Advice to the industry. Companies will be given an opportunity to provide feed-back on the service provided. (Source: MPA RSS news -)
Source: MPA RSS news - - June 27, 2007 Category: Medical Equipment Authors: Medical Products Agency, Sweden Source Type: organizations

Medical Products Agency’s assessment: additional information on dental implants is requiredEmail this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
The Medical Products Agency has now reviewed Nobel Biocare’s plan to improve the information on the dental implants NobelDirect and NobelPerfect. The Medical Products Agency’s assessment is that the instructions for use require more information in addition to the measures that the company has suggested. (Source: MPA RSS news -)
Source: MPA RSS news - - June 24, 2007 Category: Medical Equipment Authors: Medical Products Agency, Sweden Source Type: organizations

Different number of indications accepted for generic applicationsEmail this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
Since November 2006, generic applications where the generic has more or fewer indications than the reference product in the CMS are accepted. The applicant must inform the RMS of the differences between Member States. (Source: MPA RSS news -)
Source: MPA RSS news - - April 18, 2007 Category: Medical Equipment Authors: Medical Products Agency, Sweden Source Type: organizations

Computer problems dealt with - reported incidents now come through againEmail this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
Manufacturers report adverse reactions to the Medical Products Agency... At 10 a. m. on Friday 2rd March 2007 the ingoing channel to the Medical Products Agency... The computer problems were dealt with on Monday the 5th of March. During the stop many MAH have had their reports ’rejected’ because of ’Max... (Source: MPA RSS news -)
Source: MPA RSS news - - March 5, 2007 Category: Medical Equipment Authors: Medical Products Agency, Sweden Source Type: organizations

Medical Products Agency requests additional information from Nobel Biocare ABEmail this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
The Medical Projects Agency has reviewed Nobel Biocare’s plan for taking measures to improve their instructions for use for the NobelDirect and NobelPerfect dental implants. The Medical Projects Agency now requests additional information from Nobel Biocare AB. (Source: MPA RSS news -)
Source: MPA RSS news - - February 15, 2007 Category: Medical Equipment Authors: Medical Products Agency, Sweden Source Type: organizations

Drug-eluting stents should be used with utmost restraintEmail this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
The Medical Products Agency, the National Board of Health and Welfare and the Swedish Society of Cardiology call for utmost restraint in the use of drug-eluting stents. These should only be used in such rare cases where there is no alternative treatment. (Source: MPA RSS news -)
Source: MPA RSS news - - February 14, 2007 Category: Medical Equipment Authors: Medical Products Agency, Sweden Source Type: organizations

Continue sales – but with certain restrictionsEmail this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
The Swedish Medical Products Agency investigation of the dental implants NobelDirect and NobelPerfect show that there can be deficiencies in the instructions for use for the products. The Medical Products Agency has ordered the company Nobel Biocare to clarify certain information in the information materials for the products. (Source: MPA RSS news -)
Source: MPA RSS news - - December 6, 2006 Category: Medical Equipment Authors: Medical Products Agency, Sweden Source Type: organizations

Multiple applications with reference to a medicinal product with approval date before 1 may 2006Email this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
Applications for marketing authorisations should be in compliance with current... This also applies for so called multiple applications or duplicates. Application form and practical guidance are now available on the website. (Source: MPA RSS news -)
Source: MPA RSS news - - November 1, 2006 Category: Medical Equipment Authors: Medical Products Agency, Sweden Source Type: organizations

Medical Products Agency waits for further information from Nobel BiocareEmail this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
The Swedish Medical Products Agency is investigating the dental implant Nobel... Nobel Biocare has announced that they, during the first week of November... The Medical Products Agency has today decided to consider the data presented... (Source: MPA RSS news -)
Source: MPA RSS news - - October 25, 2006 Category: Medical Equipment Authors: Medical Products Agency, Sweden Source Type: organizations

Nobel Biocare clarifies information about the dental implant Nobel DirectEmail this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
Within the scope of the Swedish Medical Products Agency’s investigation of the... The meeting was held on request from Nobel Biocare and gave the company the... When the Medical Products Agency decides on the safety of the dental implant... The Medical Products Agency intends to make a decision on the dental implant... (Source: MPA RSS news -)
Source: MPA RSS news - - October 10, 2006 Category: Medical Equipment Authors: Medical Products Agency, Sweden Source Type: organizations

New regulation to facilitate professional activities for foreign veterinary surgeons in SwedenEmail this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
Under the LVFS 2006:10 regulation, veterinary surgeons who normally work in other European Economic Area (EEA) member states (EU countries plus Norway, Iceland and Liechtenstein) will be entitled to import limited quantities of pharmaceuticals for their professional operations in Sweden. A veterinary surgeon who normally works in Sweden will also be entitled to bring back unused pharmaceuticals to Sweden after serving in another EEA country. (Source: MPA RSS news -)
Source: MPA RSS news - - June 22, 2006 Category: Medical Equipment Authors: Medical Products Agency, Sweden Source Type: organizations

Commission publish guidelines on potential serious risk to public healthEmail this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
The European Commission have published the guideline on definition of potential... The guidelines were published in the Official Journal 8 June. (Source: MPA RSS news -)
Source: MPA RSS news - - June 13, 2006 Category: Medical Equipment Authors: Medical Products Agency, Sweden Source Type: organizations

New head of department for the Regulatory Administration DepartmentEmail this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
From the 1st of June Christina Wik is appointed head of the Regulatory Administration Department at Medical Product Agency, Sweden. (Source: MPA RSS news -)
Source: MPA RSS news - - May 29, 2006 Category: Medical Equipment Authors: Medical Products Agency, Sweden Source Type: organizations